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Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention (Mindfulness)

Primary Purpose

Alcohol Use Disorder

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness practice
Relapse prevention
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Mindfulness, Alcohol, Alcohol Use Disorder, Relapse, Relapse Prevention, Cognitive-behavioral therapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female aged 18 to 75 (including landmarks)
  • Patients in withdrawal for alcohol dependence according to DSM IV criteria (1994); hospital or outpatient withdrawal of more than 10 days and less than 10 weeks.

Exclusion Criteria:

  • Psychiatric comorbidity (dipsomaniac alcoholism, anteriority of one or more hypomanic or manic episodes, psychoses, severe depression, severe suicidal risk)
  • Other addiction syndrome than tobacco and alcohol
  • Problems that impede participation in a group, such as severe borderline personality disorder; antisocial personality; tendency to dissociation; phobias of interceptive type (panic attacks and hypochondria ...)
  • Problems preventing the completion of questionnaires, such as cognitive dysfunctions, dysfunctions of attention and concentration skills, or a language barrier
  • Severe recurring pathology
  • Need for individual weekly follow-up

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Relapse Prevention

Mindfulness Practice

Arm Description

Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks.

Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks.

Outcomes

Primary Outcome Measures

Number of alcoholic relapses
Proportion of patients with an alcohol consumption of at least one glass of alcohol

Secondary Outcome Measures

Alcohol relapse time
Measurement : Number of days elapsed between the end of treatment and the first relapse compare between the two interventions (classic or "mindfulness")
Delay in "heavy drinking" relapse
Measurement : Number of days elapsed between the end of treatment and the first heavy drinking (≥4 glasses of alcohol for women and ≥6 glasses of alcohol for men) compare between the two interventions (classic or "mindfulness")
Frequency of consumption
Measurement : Number of consumption days during 6 month compare between the two interventions (classic or "mindfulness")
Daily quantities consumed
Measurement : Number of standard glasses consumed per day during 6 month compare between the two interventions (classic or "mindfulness")
Degree of mindfulness skills
Measurement : Score at the KIMS Scale (Kentucky Inventory of Mindfulness Skills) evaluated each month, compare before and after intervention (classic or "mindfulness")
Severity of alcohol craving
Measurement: Assessed daily on a VAS craving (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
Level of self-efficacy
Measurement: Assessed daily on a VAS self-efficacy (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")

Full Information

First Posted
May 4, 2017
Last Updated
May 10, 2017
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Lundbeck SAS 37-45
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1. Study Identification

Unique Protocol Identification Number
NCT03150550
Brief Title
Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
Acronym
Mindfulness
Official Title
Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Lundbeck SAS 37-45

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Among behavioral cognitive psychotherapies, new "Mindfulness" interventions allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena. This "to do with" training has yielded promising results in stress management, prevention of depressive relapse, management of craving and an increase in self-efficacy. Few studies (none in France) have attempted to measure the efficacy of this technique on alcohol relapse, in particular by comparing it with a usual management strategy (conventional relapse prevention therapy). The main objective of this study is to compare the efficacy on alcoholic relapse (measured in the "first glass" consumed), from a Mindfulness therapeutic program to a conventional Relapse Prevention program. Secondary objectives are to demonstrate the efficacy of this program on craving, self-efficacy, and secondary endpoints of relapse (massive alcoholism, number of alcoholisation days).
Detailed Description
Each patient will perform 12 psychotherapeutic sessions (Mindfulness or Relapse Prevention) over a period of 6 weeks. Patients will be evaluated by a practitioner different from the practitioner who makes the psychotherapeutic management. Patients will be assessed at inclusion (Initial visit), after the 12 sessions of management (M0), 1 month (M1), 2 month (M2), 3 month (M3), 4 month (M4), 5 month (M5), 6 month (M6), after initial visit as follows Initial Visit Signature of an informed consent form. Demographic characteristics (gender, age, family status, professional status, level of education …) Clinical data (patient status, ongoing pharmacological treatment, withdrawal, previous CBT ...) Criteria and severity of alcohol dependence (DSM 5) Evaluation of depressive symptomatology and severity (HAM-D) Level of pre-intervention alcohol consumption (AUDIT-C) "Binge drinking" consumption Craving before alcohol withdrawal (EVA craving) Mindfulness Skills (KIMS) Self-efficacy to remain abstinent (QAE-Alcohol) Drinking habits (QHPBA) After the 12 sessions (M0) Data on treatments in progress or change in treatment Depressive symptomatology and severity (HAM-D) Level of alcohol consumption in post-intervention (AUDIT-C) "Binge drinking" consumption Craving after alcohol withdrawal (EVA craving) Mindfulness Skills (KIMS) Self-efficacy to remain abstinent (QAE-Alcohol) Distribution of the 1st Daily Alcohol Logbook (TLFB) At 1 month (M1) Return of the 1st Daily Alcohol Logbook (TLFB) Data on treatments in progress or change in treatment Mindfulness Skills (KIMS) "Binge drinking" consumption Self-efficacy to remain abstinent (QAE-Alcohol) Distribution of the 2nd Daily Alcohol Logbook (TLFB) At 2 month (M2) Return of the 2nd Daily Alcohol Logbook (TLFB) Data on treatments in progress or change in treatment Mindfulness Skills (KIMS) "Binge drinking" consumption Self-efficacy to remain abstinent (QAE-Alcohol) Distribution of the 3th Daily Alcohol Logbook (TLFB) At 3 month (M3) Return of the 3th Daily Alcohol Logbook (TLFB) Data on treatments in progress or change in treatment Mindfulness Skills (KIMS) "Binge drinking" consumption Self-efficacy to remain abstinent (QAE-Alcohol) Distribution of the 4th Daily Alcohol Logbook (TLFB) At 4 month (M4) Return of the 4th Daily Alcohol Logbook (TLFB) Data on treatments in progress or change in treatment Mindfulness Skills (KIMS) "Binge drinking" consumption Self-efficacy to remain abstinent (QAE-Alcohol) Distribution of the 5th Daily Alcohol Logbook (TLFB) At 5 month (M5) Return of the 5th Daily Alcohol Logbook (TLFB) Data on treatments in progress or change in treatment Mindfulness Skills (KIMS) "Binge drinking" consumption Self-efficacy to remain abstinent (QAE-Alcohol) Distribution of the 6th Daily Alcohol Logbook (TLFB) At 6 month (M6) Return of the 6th Daily Alcohol Logbook (TLFB) Data on treatments in progress or change in treatment Mindfulness Skills (KIMS) "Binge drinking" consumption Self-efficacy to remain abstinent (QAE-Alcohol)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Mindfulness, Alcohol, Alcohol Use Disorder, Relapse, Relapse Prevention, Cognitive-behavioral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Simple Blind
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relapse Prevention
Arm Type
Experimental
Arm Description
Each patient will perform 12 classic psychotherapeutic sessions over a period of 6 weeks.
Arm Title
Mindfulness Practice
Arm Type
Experimental
Arm Description
Each patient will perform 12 mindfulness psychotherapeutic sessions over a period of 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness practice
Intervention Description
Mindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena.
Intervention Type
Behavioral
Intervention Name(s)
Relapse prevention
Intervention Description
It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed.
Primary Outcome Measure Information:
Title
Number of alcoholic relapses
Description
Proportion of patients with an alcohol consumption of at least one glass of alcohol
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Alcohol relapse time
Description
Measurement : Number of days elapsed between the end of treatment and the first relapse compare between the two interventions (classic or "mindfulness")
Time Frame
6 month
Title
Delay in "heavy drinking" relapse
Description
Measurement : Number of days elapsed between the end of treatment and the first heavy drinking (≥4 glasses of alcohol for women and ≥6 glasses of alcohol for men) compare between the two interventions (classic or "mindfulness")
Time Frame
6 month
Title
Frequency of consumption
Description
Measurement : Number of consumption days during 6 month compare between the two interventions (classic or "mindfulness")
Time Frame
6 month
Title
Daily quantities consumed
Description
Measurement : Number of standard glasses consumed per day during 6 month compare between the two interventions (classic or "mindfulness")
Time Frame
6 month
Title
Degree of mindfulness skills
Description
Measurement : Score at the KIMS Scale (Kentucky Inventory of Mindfulness Skills) evaluated each month, compare before and after intervention (classic or "mindfulness")
Time Frame
6 month
Title
Severity of alcohol craving
Description
Measurement: Assessed daily on a VAS craving (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
Time Frame
6 month
Title
Level of self-efficacy
Description
Measurement: Assessed daily on a VAS self-efficacy (Visual analogue scale) in the daily observation book, compare before and after intervention (classic or "mindfulness")
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 18 to 75 (including landmarks) Patients in withdrawal for alcohol dependence according to DSM IV criteria (1994); hospital or outpatient withdrawal of more than 10 days and less than 10 weeks. Exclusion Criteria: Psychiatric comorbidity (dipsomaniac alcoholism, anteriority of one or more hypomanic or manic episodes, psychoses, severe depression, severe suicidal risk) Other addiction syndrome than tobacco and alcohol Problems that impede participation in a group, such as severe borderline personality disorder; antisocial personality; tendency to dissociation; phobias of interceptive type (panic attacks and hypochondria ...) Problems preventing the completion of questionnaires, such as cognitive dysfunctions, dysfunctions of attention and concentration skills, or a language barrier Severe recurring pathology Need for individual weekly follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julie GENESTE
Phone
04 73 75 47 84
Email
j_geneste@chu-clermontferrand.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
France
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Julie GENESTE
Phone
04 73 75 47 84
Email
j_geneste@chu-clermontferrand.fr

12. IPD Sharing Statement

Learn more about this trial

Study of Mindfulness Practice Efficacy in Alcoholic Relapse Prevention

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